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FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

7/29/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

7/3/2014 - CGMP DQSA Drug Compounding Drug Manufacturers FDA Manufacturers Outsourcing Pharmaceutical Prescription Drugs

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